Brand Name: K-Systems Product Name: R65 Trolley Model/Catalog Number: K24012 Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls. Component: N/A
Class I - DangerousWhat Should You Do?
- Check if you have this product: Version or Model: K24012; Primary DI Number: 00888937025026; Serial Numbers: 2234KH01, 2234KH02, 2234KH03, 2234KH04, 2234KH05, 2234KH06, 2234KH07, 2234KH08, 2234KH09, 2234KH10, 2235KH41, 2235KH42, 2235KH43, 2235KH44, 2235KH45, 2235KH46, 2235KH47, 2235KH48, 2235KH49, 2235KH50, 2235KH51, 2235KH52, 2235KH53, 2235KH54, 2235KH55, 2235KH56, 2235KH57, 2235KH58, 2235KH59, 2235KH60, 2243KH01, 2243KH02, 2243KH03, 2243KH04, 2243KH05, 2243KH06, 2243KH07, 2243KH08, 2243KH09, 2243KH10, 2243KH11, 2243KH12, 2243KH13, 2243KH14, 2243KH15, 2243KH16, 2243KH17, 2243KH18, 2243KH19, 2243KH20, 2307KH01, 2307KH02, 2307KH03, 2307KH04, 2307KH05, 2307KH06, 2307KH07, 2307KH08, 2307KH09, 2307KH10, 2320KH11, 2320KH12, 2320KH13, 2320KH14, 2320KH15, 2320KH16, 2320KH17, 2320KH18, 2320KH19, 2320KH20, 2337KH11, 2337KH12, 2337KH13, 2337KH14, 2337KH15, 2337KH16, 2337KH17, 2337KH18, 2337KH19, 2337KH20, 2340KH01, 2340KH02, 2340KH03, 2340KH04, 2340KH05,
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- CooperSurgical, Inc.
- Reason for Recall:
- The warming surfaces or incubator well temperatures of the listed products may exceed the desired set temperature. If temperatures exceed the desired set value, the device will alarm appropriately.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Brand Name: K-Systems Product Name: R65 Trolley Model/Catalog Number: K24012 Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls. Component: N/A
Product Codes/Lot Numbers:
Version or Model: K24012; Primary DI Number: 00888937025026; Serial Numbers: 2234KH01, 2234KH02, 2234KH03, 2234KH04, 2234KH05, 2234KH06, 2234KH07, 2234KH08, 2234KH09, 2234KH10, 2235KH41, 2235KH42, 2235KH43, 2235KH44, 2235KH45, 2235KH46, 2235KH47, 2235KH48, 2235KH49, 2235KH50, 2235KH51, 2235KH52, 2235KH53, 2235KH54, 2235KH55, 2235KH56, 2235KH57, 2235KH58, 2235KH59, 2235KH60, 2243KH01, 2243KH02, 2243KH03, 2243KH04, 2243KH05, 2243KH06, 2243KH07, 2243KH08, 2243KH09, 2243KH10, 2243KH11, 2243KH12, 2243KH13, 2243KH14, 2243KH15, 2243KH16, 2243KH17, 2243KH18, 2243KH19, 2243KH20, 2307KH01, 2307KH02, 2307KH03, 2307KH04, 2307KH05, 2307KH06, 2307KH07, 2307KH08, 2307KH09, 2307KH10, 2320KH11, 2320KH12, 2320KH13, 2320KH14, 2320KH15, 2320KH16, 2320KH17, 2320KH18, 2320KH19, 2320KH20, 2337KH11, 2337KH12, 2337KH13, 2337KH14, 2337KH15, 2337KH16, 2337KH17, 2337KH18, 2337KH19, 2337KH20, 2340KH01, 2340KH02, 2340KH03, 2340KH04, 2340KH05,
Distribution:
Nationwide distribution
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0691-2025
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